Quality and Compliance

BioTek strives to exceed customer expectations by continually improving the quality of our products. The following Product and Quality System Certifications are just some examples of our commitment to excellence:

ISO 9001/13485 Certification

BioTek maintains a Quality System that is certified to ISO 9001 and ISO 13485.  ISO 9001 defines quality systems for design, development, production, installation, testing, inspection, and service and support of products. ISO 13485 adds medical device requirements for a higher level of compliance. ISO certifications emphasize BioTek’s continued dedication to continuous improvement and customer satisfaction.

FDA Compliance

As an FDA registered medical device manufacturer, BioTek follows the guidelines of GMP (Good Manufacturing Practices) Quality System Regulations set by the FDA for both instrumentation and software development. Our products are labeled "for in vitro diagnostic use".

CE Certification

The CE mark signifies that BioTek products have been designed and tested with environmental, safety and other regulatory requirements in mind. Product type testing ensures compliance with EC Directives such as:

  • Low Voltage Directive 2006/95/EC
  • Electromagnetic Compatibility (EMC) Directive 2004/108/EC

TÜV SÜD America Certification

With this combined certification, BioTek ensures that instruments meet North American and International safety requirements.

IQ/OQ/PQ Procedures

BioTek is committed to meeting customer needs with respect to qualification testing of instrumentation in laboratories. Our procedures assist in the confirmation of initial and ongoing performance of our products. The Absorbance Test Plate is an important part of this confirmation process, allowing quick NIST traceable confirmation of optical density accuracy, linearity and plate alignment.

Certification of Compliance and Calibration

Each BioTek product comes with its own form certifying that the instrument was inspected and calibrated in accordance with published specifications of BioTek Instruments, Inc. The accuracy of the test equipment utilized is directly or indirectly traceable to the U.S. National Institute of Standards and Technology (NIST), or other national standards, through calibration at planned intervals.

 

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